Intravascular Line and Port Cleaning Methods, Methods of Administering an Agent Intravascularly, Methods of Obtaining/Testing Blood, and Devices for Performing Such Methods

ABSTRACT

An intravascular port access device includes a first component having a chamber configured to attach reversibly to an intravenous line port. A second component reversibly attaches to the first component and contains a disinfecting agent and an applicator material. The second component is configured to be reversibly received over external surfaces of the intravenous line port. A method of cleansing an intravenous line port includes providing a port cleaning device having a first component with a chamber containing a first cleaning agent. A second component includes a second cleaning agent. A third component has a microbiocidal agent and is reversibly attached to the first component. The second component is removed from the device, the external surfaces of the port are contacted with the second cleaning agent, the first cleaning agent is ejected from the chamber into the port, and the third component is used to cap the port.

RELATED PATENT DATA

This patent claims priority under 35 U.S.C. § 119 to U.S. ProvisionalApplication No. 60/747,606, which was filed May 18, 2006; and to U.S.Provisional Application No. 60/842,194, which was filed Aug. 31, 2006,and claims priority to U.S. Provisional Application No. 60/895,621,which was filed Mar. 19, 2007.

TECHNICAL FIELD

The invention pertains to intravascular port access devices,intravascular port cleaning devices, methods of cleaning anintravascular port, methods of administering an agent into anintravascular line port, methods of obtaining a blood sample from anindividual, and sets of intravascular line port caps.

BACKGROUND OF THE INVENTION

Intravenous lines, such as peripheral IV lines and central IV lines, arecommon intravenous access methods for administering medicants, nutrientsolutions, blood products, or other substances into a vein. Arteriallines are used, for example, in monitoring physiological parameters byarterial blood sampling during coronary, intensive or critical care.However, microorganism intravascular device colonization or infectioncan occur as a result from a patients' own endogenous flora or frommicroorganisms introduced from contaminated equipment or otherenvironmental contamination sources. As a result, localized or systemicinfection or septicemia can occur and can be life threatening.

Introduction of microorganisms into an intravenous line can be initiatedor facilitated during handling of a catheter, hub, associated tubing,equipment, or injection ports, especially during manipulation of linesin preparation and during initiation of fluid administration into orwithdrawal from the line. Microorganisms present on a surface of aninjection port can be introduced through the port during administration.Microorganisms present on contaminated equipment utilized foradministration can be introduced through the port causing colonizationor infection. Bacterial growth and/or aggregation in a port or cathetercan serve as the nidus for clotting, embolization and/or occlusion ofthe port or catheter. Further manipulation or administration through theport can facilitate spreading of microorganisms within the port,catheter, and lines, and ultimately into the patient's vein/arteryand/or surrounding tissue. Accordingly, it would be advantageous todevelop methods and devices for cleaning of external surfaces ofintravascular access ports and/or internal port areas to reduce risks ofcolonization and infection.

Another complication that can occur in association with an intravascularline, catheter or access port is clot formation due to blood return.Initial clot formation could extend and/or embolize into the superiorvena cava and/or the right atrium and/or right ventricle of the heart,and subsequently into the pulmonary system circulating to the lungs. Itwould be advantageous to develop methodology and devices to deliver clotdissolving or clot inhibitory agents through intravascular ports tominimize or eliminate intravascular port associated clotting.

Yet another issue that can be associated with intravascular lines islipid accumulation or build-up within the line or port. It would beadvantageous to develop methodology and devices to deliver lipolyticagents through intravascular ports to minimize or eliminate portassociated lipid build up.

SUMMARY OF THE INVENTION

In one aspect the invention pertains to an intravascular port accessdevice. The device includes a first component having a chamber and beingconfigured to attach reversibly to an intravenous line port. The secondcomponent reversibly attaches to the first component and contains adisinfecting agent and an applicator material selected from the groupconsisting of polyethylene felt sponge, polyethylene foam sponge,plastic foam sponge and silicon foam sponge. The second component isconfigured to be reversibly received over external surfaces of theintravenous line port.

In one aspect the invention encompasses an intravascular line portcleaner including a syringe barrel having a first end and a second end.A slideable piston is received into the barrel through the second end.The line port cleaner includes a first cap containing a cleansing agentand a second cap containing a microbiocidal agent.

In one aspect the invention encompasses a method of cleansing anintravenous line port. The method includes providing a port cleaningdevice comprising a first component having a chamber with a firstcleaning agent. A second component includes a second cleaning agent. Athird component has a microbiocidal agent and is reversibly attached tothe first component. The method includes removing a second componentfrom the device, contacting the external surfaces of the port with thesecond cleaning agent, injecting the first cleaning agent from thechamber into the port, removing the third component from the device, andcapping the port with the third component.

In one aspect the invention encompasses a method of obtaining a bloodsample from an individual. The method includes providing a port accessdevice having a first component including a chamber, a second componentcontaining a cleaning agent and a third component comprising amicrobiocidal agent. The third component is reversibly attached to thefirst component. The method includes removing the second component fromthe device and contacting the external surfaces of the port with thecleaning agent. The method further includes drawing blood from theindividual through the port into the chamber of the first componentremoving the third component from the device and capping the port withthe third component.

In one aspect the invention includes a set of intravascular line portcaps. The set of caps includes a first port cap containing a first agentand a first applicator material. The set further includes a second portcap containing a second agent and a second applicator material.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention are described below withreference to the following accompanying drawings.

FIG. 1 is a diagrammatic isometric view of a device in accordance withone aspect of the invention.

FIG. 2 is a diagrammatic side view of the device shown in FIG. 1.

FIG. 3 is a diagrammatic exploded view of the device shown in FIG. 1.

FIG. 4 is a diagrammatic cross-sectional view of the device shown inFIG. 1.

FIG. 5 is a diagrammatic cross-sectional view of the device shown inFIG. 1 after repositioning relative to the positioning depicted in FIG.4.

FIG. 6 is a diagrammatic isometric view of a device in accordance withanother aspect of the invention.

FIG. 7 is a diagrammatic side view of the device shown in FIG. 6.

FIG. 8 is a diagrammatic exploded view of the device of FIG. 6.

FIG. 9 is a diagrammatic cross-sectional view of the device shown inFIG. 6.

FIG. 10 is a diagrammatic view of an exemplary packaging concept for thedevice shown in FIG. 6.

FIG. 11 shows a multi-pack packaging concept for the device shown inFIG. 6.

FIG. 12 is a diagrammatic exploded view of a device in accordance withanother aspect of the invention.

FIG. 13 is a diagrammatic cross-sectional view of the device shown inFIG. 12.

FIG. 14 is a diagrammatic exploded view of a device in accordance withanother aspect of the invention.

FIG. 15 is a diagrammatic exploded view of a device in accordance withanother aspect of the invention.

FIG. 16 is a diagrammatic cross-sectional side view of the device shownin FIG. 15.

FIG. 17 is a diagrammatic isometric view of a packaging concept inaccordance with one aspect of the invention.

FIG. 18 is a diagrammatic isometric view of the packaging concept shownin FIG. 17.

FIG. 19 is another diagrammatic isometric view of the packaging conceptshown in FIG. 17.

FIG. 20 is a diagrammatic isometric view of a set of components inaccordance with one aspect of the invention.

FIG. 21 is an exploded view of the set of components depicted in FIG.20.

FIG. 22 is a diagrammatic exploded view of a packaging concept inaccordance with one aspect of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

This disclosure of the invention is submitted in furtherance of theconstitutional purposes of the U.S. Patent Laws “to promote the progressof science and useful arts” (Article 1, Section 8).

In general the invention includes devices and methodology for cleaningand/or accessing intravascular line ports. In particular applicationsdevices of the invention can be used for cleaning external surfaces of aintravascular line port followed by cleaning of the port itself and inparticular instances cleaning of intravascular lines.

In other applications devices of the invention can be utilized foradministering an agent intravascularly. During these applications, thedevices in accordance with the invention can typically be utilized tocleanse external surfaces of the port prior to utilizing the device foradministering of an agent intravascularly. In another applicationdevices of the invention can be utilized to obtain a blood sample froman individual. A device in accordance with the invention is typicallyutilized to cleanse external surfaces of a port prior to utilizing thedevice to withdraw a sample of blood from the port. The invention alsoincludes methodology for such port cleansing agent administration andblood sampling techniques.

In one embodiment, the device comprises two components. An example twocomponent device is described with reference to FIGS. 1-5.

Referring initially to FIG. 1, a port access device 10 comprises a firstcomponent 12 at a first end 14 of the device, and a second component 16at a second end 18 of the device. Second component 16 can have a tab 20or other extension feature for assisting removal of the second componentfrom the first component. First component 12 has a chamber housing 22which can be a collapsible housing. First component 12 can also comprisean extension portion 24. Referring to FIG. 2, as depicted device 10 canhave second portion 16 insertable within connector portion 24. It is tobe understood however that the invention contemplates otherconfigurations wherein second portion 16 fits over or caps extensionportion 24. It is also to be understood that the shape and dimension ofcollapsible housing 22 is but an example with alternative shapes, sizesand configurations contemplated.

Referring to FIG. 3 such shows an exploded view of the device depictedin FIGS. 1 and 2. As illustrated chamber housing 22 of device 10 canhouse a chamber 23. Connector 24 can comprise a separator 25 having anopening 29 passing therethrough. Connector 24 can further comprise areceiving port 30 for receiving a dispenser 26. Dispenser 26 in turn cancomprise a valve portion 28. Second component 16 can comprise acontainer 21.

Referring next to FIG. 4, such shows dispenser 26 with valve 28 seatedwithin receiving port 30. As depicted such valve mechanism is in the“closed” position where contents of chamber 23 are blocked from passinginto or through connector 24. Referring next to FIG. 5, application offorce upon collapsible housing 22 such as a downward pressure upon a topsurface of the housing can be utilized to displace valve device 28 fromreceiving port 30 as illustrated. Such displacement can allow passage ofthe contents of chamber 23 into or through connector portion 24.

As depicted in FIG. 4, second component 16 can contain an applicatormaterial 32. Such applicator material can be for example, a sponge orsponge-type material. Exemplary sponge-type materials can include butare not limited to polyethylene felt sponge, polyethylene foam sponge,plastic foam sponge and silicon foam sponge.

Where device 10 is to be utilized for port cleansing applications,container 21 of second component 16 will typically contain a cleansingagent. The cleansing agent can be a disinfecting agent for cleansingexternal port surfaces. The agent is not limited to a particularcleaning or disinfecting agent and can comprise for example alcohol,preferably contained in an alcohol solution comprising from about 5% toabout 99% alcohol. In particular applications the alcohol solution willcomprise 25% to 90% alcohol. The sponge-type applicator material can beutilized to assist in containing the cleansing agent and can furtherassist in applying the agent to external surfaces of the intravascularport. Second component 16 is removably attached to the device 10. Forcleansing of the port, removable component 16 is removed from firstcomponent 12 and is utilized to contact external port surfaces forcleansing of external portions of an intravascular line port.

After cleansing of external portions of the port, the first component ofthe device, which in cleansing/disinfecting applications can be utilizedfor internal cleansing of the intravascular port, can be reversiblyattached to the port to be cleansed. The chamber volume can be forexample up to 3.5 ml; a preferred volume range can be from about 1 toabout 3 ml. although alternative chamber sizes for smaller or largervolumes are contemplated. The chamber can have appropriate calibrationmarks relative to the total volume of the chamber. For example, a 3.5ml. fluid volume chamber can have volume markings every 1 ml, every 0.5ml, every 0.1 ml, etc. In particular embodiments, the connector portioncan have a LEUR-LOK® (Becton, Dickinson and Company Corp., FranklinLakes N.J.) fitting (not shown) for connection to a LEUR-LOK® type port.A cleansing agent can be provided within chamber 23 and can be anantibiotic or an alternative appropriate disinfectant. An exemplaryagent can be an alcohol or alcohol solution such as described aboverelative to the second component container 21. In cleansing applicationschamber 22 can alternatively or additionally contain chemical agentsincluding ethylene diamine tretaacetic acid (EDTA) and/or sodiumcitrate.

Once connected to the line port external pressure can be applied tocollapsible housing 22 by for example squeezing, pinching, or pushinginward on the housing to displace dispenser 26 thereby opening ordisplacing valve 28 from receiving port 30. Continued squeezing orexternal force can be utilized to dispel or eject contents of chamber 23through connector 24 and into the connected port. Depending upon thevolume of chamber 23 the injected cleansing solution may extend into theintravascular line itself. After dispelling the contents of chamber 23device component 12 can be removed from the port to allow administrationof fluids to be delivered intravascularly (for example). If suchdelivery is not to be performed immediately upon cleansing, component 12of the cleansing device can be retained on the port until such time asintravascular delivery is desired.

In another aspect, the above-described device and methodology can beutilized for administering an anti-clot agent to minimize or preventintravascular associated clot formation or to dissolve an existing clot.In this aspect, rather than or in addition to the antimicrobial agent,chamber 23 can contain an appropriate anticoagulant agent or clotdissolving agent. Exemplary anti-clot agents which can be utilizedinclude but are not limited to anticoagulants such as EDTA, sodiumcitrate, heparin and heparin derivatives, and anti-thrombolytic agentssuch as tissue plasminogen activator. Where lipid accumulation is anissue an appropriate dispersion or lipolytic agent can be administered,either independently or in combination with antimicrobial agent and/oranti-clot agent. Injection of any such agents can be achieved in amanner analogous to that described above relative to the cleansingagent. These applications may also be accomplished utilizing theembodiments illustrated and described below.

An alternative embodiment of a device in accordance with the inventionis illustrated and described with reference to FIGS. 6-11. Referring toFIG. 6, such illustrates an alternative example port access device 40having a syringe-like first component 42 and a second component 44.Referring to FIG. 7 syringe-like first component 42 includes a plunger46. An exploded view of the port access device is depicted in FIG. 8.First component 42 includes a syringe barrel-like housing 48 having afirst end 50 and a second end 52 with an internal chamber 54. Chamber 54can preferably have a fluid volume of from 1 to about 3.5 ml. Housing 48can have appropriate calibration marks as discussed above with respectto the earlier embodiment.

Plunger 46 can include a stem portion 56 having a seal 57. Plunger 46can be insertable into second end 52 of housing 48. A second seal 59 canbe associated with the larger diameter body of the plunger. Seal 59 ispreferably present to form a seal between the plunger and an internalsurface of the device chamber. Seal 59 can preferably be an elastamericseal which is over molded onto the piston (which can preferably be amolded hard plastic material). However, the invention contemplatesalternative seal material and use of non-overmolded techniques.

Seal 57 can be a single seal or a set of seals and can be for example aset of two o-rings, a single broad overmolded elastameric o-ring orsleeve or a hard plastic seal molded integrally with the piston stem.The presence of seal 57 can advantageously inhibit or prevent unwantedor unintentional backflow of fluid into the device chamber therebydecreasing the risk of contamination of the device and/or its contents.Alternatively relative to the depicted configuration a single seal canbe over molded to have a base portion which forms the seal between aninternal wall of the device chamber and the large diameter portion ofthe piston and a sleeve portion which covers the walls of the smallerdiameter portion of the piston (not shown).

The second component 44 is a removable cap portion having a housing 60and an internal container 62. Container 62 can contain an applicatormaterial 64. The applicator material can be, for example, any of thosematerials discussed above with respect to the earlier embodiment. Thesecond component 44 can additionally contain a cleansing agent such asthose cleansing agents discussed above. Second component 44 preferablycan be configured to fit over or onto an intravascular port such thatthe cleansing agent can be applied to external surfaces of the port.Such cleaning preferably can be conducted prior to administering thecontents of chamber 54 (for example, an anti-clot, antimicrobial orother cleansing agent) into the port. However, the inventioncontemplates post-administration cleansing of the port utilizing theremovable cap portion.

Referring next to FIG. 9, such shows a cross-sectional view of theembodied device 40 in an intact configuration. For utilization secondcomponent 44 can be removed and utilized to cleanse external surface ofthe port. Subsequently, first end 50 of the second component can beattached to the port and contents of the chamber 54 can be administeredinto the port by application of force to plunger 46. Alternatively,chamber 54 can be provided empty or can be provided to contain, forexample, an anticoagulant agent and device 40 can be provided withplunger 46 in a forward position. Thus device 40 can be utilized forapplications such as obtaining and/or testing of a blood sample from anindividual by attaching first end 50 of the device to the port andrepositioning of plunger 46 to draw fluid through the port into chamber54.

Referring to FIG. 10 packaging 70 for delivery, storage and/or disposalof the component for access device 40 is illustrated. Such packagingincludes a lid 72 and a tray portion 74. Tray portion 74 has a cavity 76with molded retainers 78 for positioning/retaining of the device andassisting in maintaining the integrity of the device and properpositioning of the plunger relative to the device chamber. Suchpackaging can be sealed and can be utilized to provide a sterileenvironment for device 40. As shown in FIG. 11 a series 71 of individualpackaging unit 70 can be provided with individually sealed units toallow individual removal of units while maintaining sterility ofadditional units in the series.

Another alternative embodiment is described with reference to FIGS.12-13. In this embodiment first component 42 a is the same as theimmediately preceding embodiment. However, referring to FIG. 12 secondcomponent 44 a comprises a “dual cap” system. Cap housing 60 a includescontainer portion 62 and a second cap extension 65 which houses a secondcontainer 66. Container 62 can contain an applicator material 64 such asthe sponge-like materials described above. Similarly container 66 canalso contain a sponge or other applicator material 67. Container 62 canfurther contain a cleansing agent such as those described above.

Container 66 can preferably contain one or more microbiocidal agentsthat differ in composition from the cleaning solution contained in thecleansing cap 62. An example agent composition within cap portion 65 caninclude from about 3% to about 11% H₂O₂. Additional components of theagent can include for example ethanol (from about 30% to about 40%)sodium citrate (from about 1% to about 4%), EDTA, and/or peracetic acid(less than or equal to about 11%). Preferably, the pH will be between 5and 10 and can be adjusted with NaOH or other appropriate base/acid toabout ph 7.4 as needed based upon the physiological pH and biocidalactivity. The presence of EDTA can provide sporocidal activity againstfor example bacillus spores by complexing Mn and can additionally helpstabilize H₂O₂. In combination with H₂O₂ in the solution a synergisticand/or additive effect can be achieved. The invention does contemplateuse of alternative chelators and pH stabilizers relative to thoseindicated.

It is to be noted that in some instances a similar solution having lowerperoxide content may be included within the first container 62 and inparticular instances may be present within the chamber of the firstcomponent.

Referring to FIG. 13 such shows an intact device prior to use. In portcleansing applications second component 44 a is removed from the deviceand portion 60 a is utilized to cover a port thereby contacting the portwith the contents of container 62. Applicator material 64 can assist inapplying the cleaning agent to external port surfaces. When the contentsof chamber 54 are to be administered, component 44 a is removed from theport and first component is attached to the port. Plunger 46 isdepressed thereby injecting the contents of chamber 54 into the port.The syringe component is then removed from the port. A removable seal 68can then be removed from second cap portion 65. Cap portion 65 can beplaced over the port such that the contents of container 66 contact theport. Second component 44 can then be removed from the port or can beretained on the port until further port access or manipulation isdesired.

Referring to FIG. 14 such shows an alternative embodiment wherein portaccess device 40 b comprises a first component 42 b, a second component44 b and a third component 45 b where second component 44 b and thirdcomponent 45 b are independently removable caps. As illustrated the capsare disposed initially at opposing ends of the device and are ofdiffering size. However, alternative relative size and positioning ofthe caps on the device is contemplated. For example, first component 44b and second 45 b can be disposed on top-side or bottom-side of wingextensions 51, 53 of chamber housing 48 b.

For the example configuration illustrated, the larger cap (firstcomponent 44 b) can be removed from the device and can be utilized forexternal port cleaning in a manner analogous to that described above.The second smaller cap (third component 45 b) can be removed from thedevice after administration of the chamber contents and can besubsequently utilized as a port cap to protect the port until subsequentport access is desired as described above. Third component 45 boptionally can contain an applicator material 82 and/or cleansing agentor microbiocidal agent as described above.

Alternative two-cap configurations include a device having a larger capexternal to a smaller internal cap, the first cap being removable fromthe second cap where one of the first and second caps is configured forutilization as a port cap.

In the device shown in FIG. 14, cap housing 60 b of second component 44b and cap housing 80 of third component 45 b can be of differing colors.As such, the caps can be color coded (or otherwise coded) to notify theuser or other personnel of the status of the port or intravascular line.For example, a first color such as green can be utilized on all or aportion of cap housing 80 which will be retained on the port after useof the device to signify a properly sterilized port. Cap housing 60 bcan be a second color (e.g., yellow or red) signifying the cleansing orother procedure being performed has not yet been completed. Accordingly,the caps can be utilized as an added safety measure to help ensureproper use and assist in maintaining sterility and appropriate recordkeeping. For example, the caps can allow visual monitoring and can betracked by hospital pharmacy and/or central auditing software.

In addition to visual auditing of compliance to proper cleaning andmaintenance of sterility, a barcode, radio frequency identification(RFID) and/or other pharmacy dispensary or inventory control systemassociated with the device can be utilized to provide an independentaudit/compliance system.

Referring next to FIG. 15 such depicts an additional alternateembodiment which can utilize a conventional type syringe and plungerdesign and can utilize caps in accordance with the invention.Accordingly, first component 42 c comprises a syringe housing 48 c andcan have a LEUR-LOK® fitting at first end 50. Plunger 46 c can have aconventional type piston seal 57 c configured to insert into second end52 of housing 48 c and form a seal with the walls of chamber 54 c.Second component 44 c can comprise a housing 60 c which can for examplehave an internal receiving port which fits either internally relative tothe LEUR-LOK® fitting or which fits over and covers the LEUR-LOK®fitting at first end 50 of first component housing 48 c. Third component45 c can also have housing 80 c configured such that it comprises aninternal receiving port which fits either internally relative to aLEUR-LOK® fitting or which fits over and covers the LEUR-LOK® fitting(or which can have an alternative type fitting) based upon the type ofport being cleansed.

A cross-sectional view of the device shown in FIG. 15 is illustrated inFIG. 16. Such shows the exemplary type of cap housings for coveringLEUR-LOK®-type fittings. For example third component 45 c has housing 80c comprising a portion of such housing which fits internally within aLEUR-LOK® type fitting thereby capping such fitting. In contrast secondcomponent 44 c has housing 60 c which is threaded to thread ontoLEUR-LOK® type fitting. It is to be understood that the depiction is forillustrative purposes only and that either or both caps can have thethreaded configuration or the snap in configuration. Cap housing 60 cand 80 c can further be color coded as described above.

The invention also contemplates dual cap system disposed at the distal(non-administration) end of the port cleaner device (not shown). In thisdual cap system a first “green” cap can be reversibly joined to both thedevice and also back to front in a stack relationship relative to asecond “yellow” cap. Each of the two caps can be, for example, aLEUR-LOK® type fitting cap, friction fit cap, etc. The green cap cancontain the microbiocide composition described above. The yellow cap cancontain for example the cleaning compositions discussed earlier or themicrobiocide composition as contained in the green cap since in thisconfiguration the yellow cap is not in contact with the administrationend of the device.

Possible materials for caps include, but are not limited to,polyethylene, polypropylene, and/or copolymer materials. Further, thecaps can preferably comprise a material or agent that is UV protectiveto preserve the integrity of hydrogen peroxide during storage, shipping,etc. Packaging may also contain UV protective materials to inhibitperoxide breakdown.

As mentioned above, devices of the invention can be utilized forwithdrawing blood from an individual through an intravascular catheteror intravascular port. In particular applications, the device can beutilized directly for blood testing purposes. The device chamber canpreferably have a chamber size in the range of 1 to 3 ml, withappropriate calibration marks as discussed above. Where whole blood isdesired, depending upon the particular purpose for drawing, blood can bedrawn into either a device having an empty chamber or into a devicecontaining an anticoagulant such as EDTA, sodium citrate or alternativecoagulant (such as discussed above). The device containing blood andanticoagulant can then be utilized directly in blood testing equipmentor blood can be transferred to an alternative device for testing.

In applications where serum is desired, whole blood can be drawn intothe device chamber and, after coagulation, the device containing theblood sample can be spun to separate the serum from the red blood cells.If anticoagulant is present in the device chamber, further separationcan occur to isolate plasma. Alternatively, a filter such as aMILLIPORE® (Millipore Corp., Bedford Mass.) filter can be fitted ontothe device after a sample is drawn into the device chamber. Suchtechnique can filter out red blood cells, white blood cells andplatelets allowing serum to flow from the chamber while retaining theblood cells within the filter. Anticoagulants can optionally be providedwithin the chamber to allow transfer of blood cells or plasma if such isdesired based upon the testing or other procedure to be performed (i.e.,complete blood count, CBC, platelet count, reticulocyte count, T and Blymphocyte assays and chemistries).

An appropriate filter can also be utilized to filter out particulatesduring drawing of a blood sample from an individual into the chamber.

It is to be understood that any of the devices above can be utilized forcleansing purposes, for administration purposes or for blooddrawing/testing purposes. Methodology will be analogous with variationbased upon the particular device utilized as described above.

Example device packaging is illustrated in FIGS. 17-19. Packaging 100can include a lid portion 102 and a packaging tray 104 as shown in FIG.17. Referring to FIGS. 18 and 19 packaging tray 104 can be a molded traywhich has integrally molded retaining features which conform to theshape of a device 40 c in accordance with the invention. Preferably themolded features conform to the shape of the device in the non-deployedposition for shipment, storage, etc. Accordingly tray 104 can have oneor more integrally molded retainer features 106, 107, 108 and 109. Tray104 can also comprise an integrally molded receiving stand 110 which canbe configured to receive device 40 c in an upright position as depictedin FIG. 18. Such receiving stand can allow device 40 c to be insertedand retained during administrative procedures or after use. Tray 104 mayalso be used for device disposal purposes.

Device caps in accordance with the invention can be utilized independentof the devices for cleansing and protection of alternative accesscatheters and ports such as intravascular, peritoneal dialysis, urinaryports and catheters, etc. Accordingly, the caps can be packagedindependently in pairs (one each of two differing sizes, colors, etc.,in groups or in bulk, of one or more colors). FIGS. 20-21 show anexample two cap packaging system 115 having a first cap 117 which can befor example a yellow cap and which can preferably be a LEUR-LOK® typecap and a second cap 118 which can be, for example, a green cap andwhich can also be a LEUR-LOK®. Packaging system 115 can comprise apackaging tray 120 and as illustrated in FIG. 21 can include integrallymolded appropriate receiving ports/receiving rings 122, 124. Whereadditional or fewer caps are to be packaged together tray 120 can havean appropriate number of receiving ports for receiving and reversiblyretaining the caps. Where the caps differ in size (diametric), the portscan also be of differing size as appropriate. It is to be understoodthat the caps may be provided in groups such as one green and fouryellow caps per package or any other appropriate number depending uponthe particular procedure for which they will be utilized with the numberand size of package ports corresponding to the number and size ofvarious caps.

Referring next to FIG. 22 an alternative packaging system 130 isillustrated. Packaging system 130 comprises a lid 132 and a tray 130having integral receiving ports 136 and 138 for receiving caps 117 and118. As discussed above alternative numbers and sizes of receiving portscan be provided based upon the number and sizes of caps to be utilized.

Where caps are provided in bulk, such may be individually packaged andmay be provided individually in sheets or on strips. Caps canalternatively be provided with catheter or line/import devices. Such canbe included in common packaging either loose or attached to a portcatheter or line to be used for port cleaning and/or protection afterpackage opening and/or while the device is in use. In some instances thecap(s) can be packaged in one or more sub-packages included within alarger package enclosing the catheter device.

In compliance with the statute, the invention has been described inlanguage more or less specific as to structural and methodical features.It is to be understood, however, that the invention is not limited tothe specific features shown and described, since the means hereindisclosed comprise preferred forms of putting the invention into effect.The invention is, therefore, claimed in any of its forms ormodifications within the proper scope of the appended claimsappropriately interpreted in accordance with the doctrine ofequivalents.

1. An intravascular port access device comprising: a first component having a chamber and being configured to attach reversibly to an intravenous line port; and a second component reversibly attached to the first component and containing a disinfecting agent and an applicator material selected from the group consisting of polyethylene felt sponge, polyethylene foam sponge, plastic foam sponge and silicone foam sponge; the second component being configured to be reversibly received over external surfaces of the intravenous line port.
 2. The device of claim 1 wherein the chamber has a volume of less than or equal to about 3.5 ml.
 3. The device of claim 1 wherein the chamber contains a cleansing agent.
 4. The device of claim 1 wherein the chamber contains an anticoagulant.
 5. The device of claim 1 wherein the chamber contains a lipolytic agent.
 6. The device of claim 1 further comprising a third component reversibly attached to the first component.
 7. The device of claim 6 wherein the third component contains a microbiocidal agent.
 8. The device of claim 7 wherein the microbiocidal agent comprises H₂O₂.
 9. The device of claim 1 wherein the first component comprises a collapsible chamber housing.
 10. The device of claim 1 wherein the first component comprises a syringe barrel chamber housing.
 11. An intravascular line port cleaner, comprising: a syringe barrel having a first end and a second end; a slideable piston received into the barrel through the second end; a first cap containing a cleansing agent; and a second cap containing a microbiocidal agent.
 12. The port cleaner of claim 11 wherein the syringe barrel contains a cleansing agent.
 13. The port cleaner of claim 11 wherein the syringe barrel contains an anticoagulant.
 14. The port cleaner of claim 11 wherein the syringe barrel contains a lipolytic agent.
 15. The port cleaner of claim 11 wherein the first and second caps each contain an applicator material.
 16. A method of cleansing an intravenous line port, comprising: providing a port cleaning device comprising: a first component having a chamber comprising a first cleaning agent; a second component comprising a second cleaning agent; and a third component comprising a microbiocidal agent reversibly attached to the first component; removing the second component from the device; contacting external surfaces of the port with the second cleaning agent; injecting the first cleaning agent from the chamber into the port; removing the third component from the device; and capping the port with the third component.
 17. The method of claim 16 wherein prior to removal the second component is reversibly attached to the third component.
 18. The method of claim 17 wherein the first cleansing agent and the microbiocidal agent comprise H₂O₂.
 19. The method of claim 16 wherein prior to removal the second component is reversibly attached to the first component.
 20. The method of claim 16 wherein the first component is a syringe device.
 21. The method of claim 12 wherein the second component comprises a first color and the third component comprises a second color differing from the first color.
 22. The method of claim 12 wherein the second and third components are caps.
 23. The method of claim 12 wherein the second and third components are caps comprising synthetic sponge material.
 24. The method of claim 12 wherein the second and third components are LEUR-LOK® fitting caps and wherein the port is a LEUR-LOK® type port.
 25. A method of administering an agent into an intravascular line port, comprising: providing a port access device comprising: a first component having a chamber comprising an agent to be administered into an intravascular line port; a second component comprising a cleaning agent; and a third component comprising a microbiocidal agent reversibly attached to the first component; removing the second component from the device; contacting external surfaces of the port with the second cleaning agent; injecting the agent to be administered from the chamber into the port; removing the third component from the device; and capping the port with the third component.
 26. The method of claim 25 wherein the agent to be administered is selected from the group consisting of an anticoagulant, an acidic solution, a basic solution, and a lipolytic agent.
 27. The method of claim 25 wherein the first component is a syringe device.
 28. The method of claim 25 wherein the first component comprises a collapsible chamber housing.
 29. The method of claim 28 wherein the first component further comprises a sildeable valve and a delivery channel.
 30. A method of obtaining a blood sample from an individual comprising: providing a port access device comprising: a first component having a chamber; a second component comprising a cleaning agent; and a third component comprising a microbiocidal agent reversibly attached to the first component; removing the second component from the device; contacting external surfaces of the port with the second cleaning agent; drawing blood from the individual through the port into the chamber of the first component; removing the third component from the device; and capping the port with the third component.
 31. The method of claim 30 wherein the chamber comprises an anticoagulant.
 32. A set of intravascular line port caps, comprising: a first port cap containing a first agent and a first applicator material; and a second port cap containing a second agent and a second applicator material.
 33. The set of caps of claim 32 wherein the first agent is a cleansing agent and the second agent is a microbiocidal agent.
 34. The set of caps of claim 32 wherein at least one of the first agent and the second agent comprises H₂O₂.
 35. The set of caps of claim 32 wherein the first and second caps differ in color relative to each other.
 36. The set of caps of claim 32 wherein the first and second caps differ in size relative to each other.
 37. The set of caps of claim 32 further comprising a packaging component having a first receiving port and a second receiving port. 